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Associate Director, Immunology TA, China Regulatory Affairs

Key Responsibilities

1. Regulatory Strategy Development and Execution

• Develop and execute end-to-end regulatory strategies for assigned immunology assets and indications in China, spanning early development, late-stage development, NDA/BLA submission, review, approval, and post-approval lifecycle management.
• Provide strategic input to global regulatory strategy plan, asset development plan, and project-related discussions to ensure China-specific considerations are incorporated early and effectively.
• Identify opportunities to optimize regulatory pathways, accelerate regulatory approvals, enhance registration success, and maximize patient access.
• Assess regulatory risks and uncertainties; collaborate with cross-functional teams to develop and implement effective mitigation plans.
• Provide regulatory leadership to address complex regulatory challenges and drive the resolution of critical regulatory issues.

2. Regulatory Expertise and Strategic Assessment

• Maintain deep understanding of the China regulatory environment, evolving regulations, health authority expectations, industry trends, competitor intelligence, and the immunology therapeutic area.
• Monitor and assess evolving regulatory requirements, policies, and agency expectations that may impact product development and registration.
• Translate changes in the regulatory environment into actionable recommendations and regulatory strategy adjustments to support development, approval, and lifecycle management of assigned assets.

3. Regulatory Submission and Approval

• Develop China regulatory submission strategy and timeline for assigned assets and get alignment with cross-functional stakeholders across China, regional and global teams.
• Partner with RE, RMC and NGS teams to deliver regulatory submissions, including CTA, NDA/BLA, supplements, variations, and renewals, and achieve regulatory milestones.
• Ensure regulatory activities are effectively planned, tracked, and executed to support timely approvals.

• Review key submission documents, health authority response and labeling content to ensure scientific rigor, quality, consistency and regulatory compliance.

4. Health Authority Interaction

• Develop and execute health authority interaction strategies, including consultation meetings and regulatory communications.
• Lead interactions with regulatory agencies to facilitate alignment on development plans, submission strategies, and key regulatory issues.
• Develop and coordinate high-quality, data-driven responses to health authority questions and information requests.
• Lead the preparation of briefing books, presentation materials, and supporting documentation for regulatory agency meetings.

5. Stakeholder Management and Business Partnership

• Represent China Regulatory Affairs on Global Regulatory Teams, China Project Teams, and other cross-functional forums for assigned assets.

• Act as a strategic partner to cross-functional and business teams, ensuring regulatory considerations are integrated into key decisions.

• Communicate regulatory strategies, submission/approval timeline, key risks, and significant regulatory developments to relevant stakeholders in a timely manner.

6. Coaching & Knowledge Sharing

• Provide coaching and guidance to junior RA colleagues and contribute to their professional development.

• Share regulatory expertise and best practices to promote regulatory excellence across the team.

Job Requirements

• Bachelor’s degree or above in Pharmacy, Chemistry, Biology, or a related life sciences discipline; advanced degree preferred.
• Minimum 10 years of regulatory affairs experience in multinational and/or leading pharmaceutical companies.
• Strong experience in drug development and registration across multiple products and development stages.
• In-depth knowledge of China regulatory requirements, guidelines, regulatory processes, and health authority expectations.
• Proven ability to work effectively in cross-functional and matrix team environments.  
• Strong strategic thinking, problem-solving, communication, influencing, and stakeholder management skills.
• Therapeutic area experience in Immunology is preferred.
• Excellent written and verbal communication skills in both English and Chinese.

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